BETADINE MISTETTE

Main information

  • Trade name:
  • BETADINE MISTETTE
  • Dosage:
  • 10 %w/v
  • Pharmaceutical form:
  • Cutaneous Spray Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETADINE MISTETTE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1175/002/018
  • Authorization date:
  • 11-02-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineMistette10.0%w/v

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Povidoneiodine10.0%w/v.

Eachmlcontains3partspermillionfreeiodine.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneousspraysolution

Areddishbrownclearsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticforthelocalmanagementofminorskintraumaandthepreparationofskinforsurgical

procedures.

4.2Posologyandmethodofadministration

Fortopicaluseonly.

Applylocallytoaffectedarea.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoiodine.Useinchildrenunder2yearsofage.Useinpatientswith

thyroiddisorders.

4.4Specialwarningsandprecautionsforuse

Useofthispreparationmayinterferewithtestsofthyroidfunction.Specialcautionisneededwhenregularapplications

tobrokenskinaremadeinpatientswithpre-existingrenalinsufficiency.Regularuseshouldbeavoidedinpatientson

concurrentlithiumtherapy.Ifusedforprolongedperiods,thyroidfunctiontestsshouldbeperformed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Regularuseshouldbeavoidedinpregnantorlactatingwomenasabsorbediodinecancrosstheplacentalbarrierand

Irish Medicines Board

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4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Localskinreactionscanoccur.Applicationtolargewoundsorsevereburns,canproducesystemicadverseeffectssuch

asmetabolicacidosis,hypernatraemiaandimpairmentofrenalfunction.

4.9Overdose

Duetothenatureofthisproduct,overdoseishighlyunlikely.However,excessiodinecanproducegoitreand

hypothyroidismorhyperthyroidism.Systemicabsorptionofiodineafterrepeatedapplicationsofpovidoneiodineto

largeareasofwoundsorburnsmayleadtoanumberofadverseeffects:metallictasteinmouth,increasedsalivation,

burningorpaininthethroatormouth,irritation,swellingoftheeyes,pulmonaryoedema,skinreactions,

gastrointestinalupsetanddiarrhoea,metabolicacidosis,hypernatraemia,renalimpairment.Inthecaseofaccidental

ingestionoflargequantitiesofBetadine,symptomaticandsupportivetreatmentshouldbeprovidedwithspecial

attentiontoelectrolytebalanceandrenalandthyroidfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Povidoneiodineisacomplexofiodine,whichretainsthebroadspectrumgermicidalactivityoftheelementaliodine

withoutitsdisadvantages.Thegermicidalactivityismaintainedinthepresenceofblood,pus,serumandnecrotic

tissue.Itisthereforesuitableforuseasabroadspectrumtopicalantisepticforthepreventionofinfectioninminorcuts,

smallareasofburnsandtreatmentofbacterialskininfectionsandpyodermas,includinginfectioni.e.decubitusand

venousulcers.

5.2Pharmacokineticproperties

Atthelevelsofiodinereleasedfrothepovidoneiodinecomplexinthispresentation,littlesystemicabsorptionwould

beexpected.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Aqueoussodiumhydroxide

Polyoxyethylenenonylphenolalcohol

Phosphatebuffersolution

Industrialmethylatedspirit

Purifiedwater

6.2Incompatibilities

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6.3ShelfLife

24months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

WhitePVCcontainerfittedwithapolyethyleneactuatorandapolyethylenediptube,containing100mlofproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLtd.

TubitonHouse

MedlockSt.

Oldham

Lancashire

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA1175/2/18

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08April1987

Dateoflastrenewal:08April2002

10DATEOFREVISIONOFTHETEXT

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